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Sorrell v. IMS Health, 6-3 for the companies

June 23, 2011 at 12:08 pm

Kevin Outterson

SCOTUS struck down Vermont’s prescription privacy law this morning, 6-3. Kennedy wrote the majority opinion, joined by the conservatives plus Justice Sotomayor. (Prior TIE coverage here)

The Court didn’t hesitate to call health care information databases “speech” worthy of First Amendment protection, but the majority applied a “heightened scrutiny” standard as opposed to the lower “intermediate scrutiny” standard.

The Vermont statute suffered from self-inflicted wounds, namely some incautious comments in the preamble that the plaintiffs/respondents hammered away at: Vermont said it was intervening in the “marketplace of ideas” by regulating the use of prescriber-identifiable information for pharmaceutical marketing. Bad move.

Implications:

Vermont can fix the statute quite easily with the guidance given by the Court. One way would be to make the statute a narrow extension of HIPAA,* giving the privacy right exclusively to the patient and a confidentiality right directly to the physician. Alternatively, Vermont can ban data mining by contract with participating pharmacies through Green Mountain Care. Vermont could also clarify that pharmacies collect this information only as a state-mandated record.

Some worried that this decision would spell the end of FDA off-label promotion restrictions – which are limitations on commercial speech in a similar context. The decision will not calm these fears. The majority offered a distinction that might be used to permit off-label promotion to physicians but not consumers:

But the “fear that people would make bad decisions if given truthful information” cannot justify content-based burdens on speech. Thompson, 535 U. S., at 374; see also Virginia Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U. S. 748, 769–770 (1976). “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.” 44 Liquormart, supra, at 503 (opinion of Stevens, J.); see also Linmark Associates, Inc. v. Willingboro, 431 U. S. 85, 97 (1977). These precepts apply with full force when the audience, in this case prescribing physicians, consists of “sophisticated and experienced” consumers. Edenfield, 507 U. S., at 775.

It is clear that the majority didn’t understand how HIPPA exceptions work, even though that was explained in several briefs. They assumed that once the data was used by insurers and providers for payment and treatment, then all privacy rights were extinguished. Try telling that to Mass General, who recently paid a fine for accidentally losing some patient information on the T. The dissent highlights some of the information Vermont put into the record, including my first citation in a SCOTUS opinion (alas, in the dissent).

Since ordinary regulatory programs can affect speech, particularly commercial speech, in myriad ways, to apply a “heightened” First Amendment standard of review whenever such a program burdens speech would transfer from legislatures to judges the primary power to weigh ends and to choose means, threatening to distort or undermine legitimate legislative objectives… To apply a “heightened” standard of review in such cases as a matter of course would risk what then-Justice Rehnquist, dissenting in Central Hudson, described as a “retur[n] to the bygone era of Lochner v. New York, 198 U. S. 45 (1905), in which it was common practice for this Court to strike down economic regulations adopted by a State based on the Court’s own notions of the most appropriate means for the State to implement its considered policies.” 447 U. S., at 589.

Bottom line: Vermont can fix this, but this case spells trouble for any federal or state regulation of data or information.

“For instance, the State might have advanced its asserted privacy interest by allowing the information’s sale or disclosure in only a few narrow and well-justified circumstances. See, e.g., Health Insurance Portability and Accountability Act of 1996, 42 U. S. C. §1320d–2; 45 CFR pts. 160 and 164 (2010). A statute of that type would present quite a different case than the one presented here. But the State did not enact a statute with that purpose or design.”

Kevin
Can you help clarify boundaries between commercial vs. non-commercial free speach?

When something veer into the public health domain for example–when can govt step in and say, “you cant say that?” For example, products of dubious health value, that might have untoward health consequences (“use at your won risk”); under interpretation of this decision have the reins loosened and companies can do things that they might not have done before?

If yes, can you give an example or two–besides the action in the case–whereby this ruling will open up doors that may worsen, not improve,how we inform general public of health information (or at least how corporate interests might)?

Thanks
Brad

ps–try as i may, even legal cases summarized in lay press confuse the heck out of me. I wish writers would take the time and pay more attention to precedents behind cases, explain the legal jargon, etc., and in as simple terms as possible, walk through the how’s and why’s. Sometimes I finish reading, and wonder why I just spent 5-10 minutes looking at “words.”